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Name of the Trial

Phase II Study of Satraplatin and Prednisone in Patients with Progressive, Metastatic Androgen-Independent Prostate Cancer (NCI-08-C-0074). See the protocol summary.

Principal Investigator

Dr. William Dahut Principal Investigator

Dr. William Dahut, NCI Center for Cancer Research

Why This Trial Is Important

Men with metastatic prostate cancer that does not respond to hormone therapy (androgen-independent prostate cancer) have very few treatment options available. Chemotherapy with docetaxel or other drugs is often used to alleviate symptoms and delay disease progression, but most men continue to get worse despite this treatment.

Satraplatin is a third-generation, orally administered platinum drug that may delay disease progression in men with androgen-independent prostate cancer. Previous preclinical and clinical research has shown that satraplatin is active against androgen-independent prostate cancer and that it may overcome the resistance to platinum drugs commonly seen in advanced disease.

In this trial, men with androgen-independent metastatic prostate cancer that has progressed after first-line chemotherapy will be treated with satraplatin and prednisone. The researchers want to see if this regimen can delay disease progression and if alterations in the ERCC1 gene are associated with improved progression-free survival. ERCC1 is an important DNA repair gene that may contribute to resistance to platinum drugs. The researchers believe that DNA variations in ERCC1 may be related to satraplatin's observed ability to overcome this resistance.

"A phase III study of satraplatin and prednisone in patients with metastatic androgen-independent prostate cancer has demonstrated that satraplatin can significantly improve progression-free survival and help alleviate cancer-related pain, although patients receiving satraplatin in this study did not live longer overall than those receiving a placebo," said Dr. Dahut.

"Our trial is unique because it aims to determine whether the presence of ERCC1 gene polymorphisms may be associated with an impact on the progression-free survival of patients with metastatic prostate cancer," he said. "This trial will provide critical information about patient selection for satraplatin therapy."

For More Information

See the lists of entry criteria and trial contact information, or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The call is toll-free and confidential.

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